EP1800689A4 - Liquid preparation of physiologically active peptide - Google Patents

Liquid preparation of physiologically active peptide

Info

Publication number
EP1800689A4
EP1800689A4 EP05774895A EP05774895A EP1800689A4 EP 1800689 A4 EP1800689 A4 EP 1800689A4 EP 05774895 A EP05774895 A EP 05774895A EP 05774895 A EP05774895 A EP 05774895A EP 1800689 A4 EP1800689 A4 EP 1800689A4
Authority
EP
European Patent Office
Prior art keywords
physiologically active
liquid preparation
active peptide
peptide
physiologically
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP05774895A
Other languages
German (de)
French (fr)
Other versions
EP1800689B1 (en
EP1800689A1 (en
Inventor
Masaru Matsumoto
Masako Matsumoto
Takeshi Hanada
Naomi Wakabayashi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Daiichi Sankyo Co Ltd
Original Assignee
Asubio Pharma Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Asubio Pharma Co Ltd filed Critical Asubio Pharma Co Ltd
Publication of EP1800689A1 publication Critical patent/EP1800689A1/en
Publication of EP1800689A4 publication Critical patent/EP1800689A4/en
Application granted granted Critical
Publication of EP1800689B1 publication Critical patent/EP1800689B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
EP05774895.6A 2004-08-24 2005-08-24 Liquid preparation of physiologically active peptide Active EP1800689B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2004244339 2004-08-24
PCT/JP2005/015362 WO2006022301A1 (en) 2004-08-24 2005-08-24 Liquid preparation of physiologically active peptide

Publications (3)

Publication Number Publication Date
EP1800689A1 EP1800689A1 (en) 2007-06-27
EP1800689A4 true EP1800689A4 (en) 2009-09-23
EP1800689B1 EP1800689B1 (en) 2016-12-28

Family

ID=35967510

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05774895.6A Active EP1800689B1 (en) 2004-08-24 2005-08-24 Liquid preparation of physiologically active peptide

Country Status (11)

Country Link
US (2) US20080193997A1 (en)
EP (1) EP1800689B1 (en)
JP (1) JP4951344B2 (en)
KR (1) KR101149454B1 (en)
CN (1) CN101022822B (en)
AU (1) AU2005275779B2 (en)
BR (1) BRPI0514408B8 (en)
CA (1) CA2576473C (en)
ES (1) ES2620326T3 (en)
IL (1) IL181348A (en)
WO (1) WO2006022301A1 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080003220A1 (en) * 2006-04-21 2008-01-03 Amgen, Inc. Buffering agents for biopharmaceutical formulations
KR101466933B1 (en) 2006-07-11 2014-12-01 큐피에스 엘엘씨 Pharmaceutical compositions for sustained release delivery of peptides
ES2672902T3 (en) 2010-02-24 2018-06-18 Arecor Limited Protein formulations
JP6118251B2 (en) * 2011-08-25 2017-04-19 株式会社Ｌｓｉメディエンス Method for measuring glucagon-like peptide-1 and kit used therefor
US20150011473A1 (en) * 2012-01-20 2015-01-08 Lupin Limited Stabilized pth formulation
CN103301058A (en) * 2013-06-17 2013-09-18 深圳翰宇药业股份有限公司 Composition for teriparatide injection, and preparation method and preparation thereof
EP2823808A1 (en) * 2013-07-09 2015-01-14 Ipsen Pharma S.A.S. Pharmaceutical composition for a sustained release of lanreotide
NL2015865B1 (en) 2015-11-27 2017-06-13 Le Vet B V Maropitant Formulation.
EP3685850A4 (en) 2017-09-22 2021-06-16 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent pharmacodynamics and/or stability
JP6577683B2 (en) * 2017-09-22 2019-09-18 旭化成ファーマ株式会社 Liquid pharmaceutical composition containing teriparatide having excellent stability
CN116718762A (en) * 2023-06-09 2023-09-08 上海品峰医疗科技有限公司 Polypeptide sample stabilizer

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB770075A (en) * 1954-03-15 1957-03-13 Cutter Lab Improvements in or relating to preparation of a fibrinogen product and stable solutions thereof
WO1993019776A1 (en) * 1992-04-03 1993-10-14 Kabi Pharmacia Ab Protein formulation comprising growth hormone
WO1998028007A1 (en) * 1996-12-24 1998-07-02 Biogen, Inc. Stable liquid interferon formulations

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0651637B2 (en) 1985-03-28 1994-07-06 エーザイ株式会社 Peptide adsorption prevention composition
JPH0669956B2 (en) 1988-09-30 1994-09-07 旭化成工業株式会社 Anti-adsorption agent for polypeptides
JPH032136A (en) 1989-05-30 1991-01-08 Asahi Glass Co Ltd Production of double metal cyanide complex and use thereof
JPH0397083A (en) 1989-09-08 1991-04-23 Tokyo Electric Co Ltd Label issuing device
DE4126983A1 (en) 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh METHOD FOR THE PRODUCTION OF HUMAN-PROTEIN-CONTAINING, PRESERVED MEDICAMENTS FOR INFUSION OR INJECTION USE
SE9300105D0 (en) * 1993-01-15 1993-01-15 Kabi Pharmacia Ab STABLE PROTEIN SOLUTION
US5482931A (en) 1993-06-29 1996-01-09 Ferring Ab Stabilized pharmaceutical peptide compositions
DE4340781C3 (en) * 1993-11-30 2000-01-27 Novartis Ag Liquid preparations containing cyclosporin and process for their preparation
TW426523B (en) * 1995-04-06 2001-03-21 Hoffmann La Roche Interferon solution
US5780431A (en) * 1996-09-20 1998-07-14 Neurobiological Technologies, Inc. Pharmaceutical formulations of corticotropin releasing factor having improved stability in liquid form
US6440930B1 (en) * 1998-09-17 2002-08-27 Eli Lilly And Company Protein formulations
US20020061838A1 (en) * 2000-05-17 2002-05-23 Barton Holmquist Peptide pharmaceutical formulations
AU785444B2 (en) * 2000-05-19 2007-06-14 Jefferson Pharmaceuticals, Llc Peptide pharmaceutical formulations
CA2411667A1 (en) 2000-05-30 2001-12-06 Merck & Co. Inc. Ghrelin analogs
ATE382057T1 (en) * 2001-06-28 2008-01-15 Novo Nordisk As STABLE FORMULATION OF MODIFIED GLP-1
IL162796A0 (en) 2002-05-21 2005-11-20 Kenji Kangawa Medicinal compositions containing ghrelin
EP1407779A1 (en) * 2002-10-10 2004-04-14 Gastrotech A/S Use of ghrelin for treating low body weight and body fat in gastrectomized individuals

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB770075A (en) * 1954-03-15 1957-03-13 Cutter Lab Improvements in or relating to preparation of a fibrinogen product and stable solutions thereof
WO1993019776A1 (en) * 1992-04-03 1993-10-14 Kabi Pharmacia Ab Protein formulation comprising growth hormone
WO1998028007A1 (en) * 1996-12-24 1998-07-02 Biogen, Inc. Stable liquid interferon formulations

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2006022301A1 *

Also Published As

Publication number Publication date
EP1800689B1 (en) 2016-12-28
BRPI0514408B1 (en) 2021-02-23
CN101022822A (en) 2007-08-22
IL181348A (en) 2014-06-30
US20080193997A1 (en) 2008-08-14
BRPI0514408A (en) 2008-06-10
JP4951344B2 (en) 2012-06-13
JPWO2006022301A1 (en) 2008-05-08
BRPI0514408B8 (en) 2021-05-25
CA2576473C (en) 2015-06-30
CA2576473A1 (en) 2006-03-02
IL181348A0 (en) 2007-07-04
AU2005275779A1 (en) 2006-03-02
AU2005275779B2 (en) 2011-09-15
EP1800689A1 (en) 2007-06-27
WO2006022301A1 (en) 2006-03-02
US8969298B2 (en) 2015-03-03
CN101022822B (en) 2012-06-27
ES2620326T3 (en) 2017-06-28
KR20070057850A (en) 2007-06-07
KR101149454B1 (en) 2012-05-25
US20110077195A1 (en) 2011-03-31

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